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Priorix-Tetra · 2 trials · 5 indications
Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Concentrations are given as Geometric Mean Concentrations (GMCs).
| Arm | Type | Description |
|---|---|---|
| MMRV Group | EXPERIMENTAL | Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| OKAH Group | EXPERIMENTAL | Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm. |
| MMR Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| Group A | EXPERIMENTAL | Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Group B | EXPERIMENTAL | Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Group C | ACTIVE_COMPARATOR | Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180 |
| Name | Type | Description |
|---|---|---|
| Priorix-tetra™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group |
| Priorix™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group |
| Varilrix™ | BIOLOGICAL | 1 dose administered subcutaneously at Day 42 to subjects in OKAH Group |
| Priorix-Tetra™ (MMRV vaccine 208136) | BIOLOGICAL | One subcutaneous injection. |
| ProQuad® | BIOLOGICAL | One subcutaneous injection. |
| Havrix® | BIOLOGICAL | Two intramuscular injections. |
| Prevnar® | BIOLOGICAL | One intramuscular injection. |
Inclusion criteria: * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study. * Male or female subject between 12 and 22 months of age at the time of the first vaccination. * Subjects fre...
Priorix-Tetra is a vaccine used for the prevention of varicella (chickenpox) and rubella, as well as measles and mumps. It is being developed by GSK plc for use in children, with clinical trials evaluating its immunogenicity and safety in healthy pediatric populations.
Priorix-Tetra is a vaccine that targets the viruses causing varicella (chickenpox), rubella, measles, and mumps. It is designed to induce an immune response against these four viral diseases, providing protection through vaccination.
Priorix-Tetra is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and efficacy in pediatric populations.
Priorix-Tetra has completed Phase 3 clinical trials, with two Phase 3 studies and one Phase 2 study finished. It is an investigational vaccine still in clinical development, and it is not yet approved by regulatory authorities.
Priorix-Tetra has been studied in completed clinical trials, including NCT00226499 (Phase 3, enrolling 5,803 children across multiple countries) and NCT01506193 (Phase 3, enrolling 716 children in Italy). A Phase 2 trial, NCT00578175, enrolled 1,851 children in the United States.
Priorix-Tetra is not the same as ProQuad, but it was compared against ProQuad in a clinical trial. The Phase 2 study NCT00578175 evaluated the immunogenicity and safety of GSK's MMRV vaccine versus ProQuad in children aged 12-14 months.